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Trial record 39 of 51 for:    Myotonic Dystrophy

Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930408
Recruitment Status : Terminated
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Tracking Information
First Submitted Date  ICMJE October 10, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • Ventricular Ejection Fraction Left 3D [ Time Frame: Immediately ]
  • Global longitudinal systolic Strain [ Time Frame: Immediately ]
  • Strain of the dispersion index [ Time Frame: Immediately ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects
Official Title  ICMJE Not Provided
Brief Summary Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE Steinert's Disease
Intervention  ICMJE
  • Procedure: electrocardiogram
  • Procedure: Echocardiography
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 11, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients suffering from muscular dystrophy type 1 followed CHU Poitiers.
  • age ≥ 18 years

Exclusion Criteria:

  • duration QRS> 120 ms ECG permanent ventricular stimulation
  • trouble segmental kinetic obvious to echocardiography in visual analysis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02930408
Other Study ID Numbers  ICMJE STEINECHO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Poitiers University Hospital
Study Sponsor  ICMJE Poitiers University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poitiers University Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP